Trusted by pharma leaders worldwide

Build Regulatory Content with Confidence

Automate 70-80% of regulatory authoring.
Reduce submission time from months to weeks.

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Across the drug lifecycle, regulatory teams manage expanding volumes of interdependent documents, where small inconsistencies introduce risk and cause significant downstream delays.

Pre-Approval

High-volume documentation to move from discovery to registration.

IND packages (pre-cllinical, CMC, clinical plans).
Protocols, amendments, IBs.
CSRs, safety narratives, ISS/ISE.
Early Module 2 and Module 3 summaries.

High volume. Constant updates. Multiple contributers.

Approval

Complex submissions required to secure market authorization.

Full CTD/eCTD dossiers (Modules 1–5).
Country-specific variations and forms.
HA queries, IRs, 483s, CRLs.
Advisory committee briefing packages.
eCTD publishing & technical validation.

Months of assembly; small errors cause major delays.

Post-Approval

Ongoing documentation to maintain global market access.

Labeling updates and CMC variations.
Renewals, supplements, market expansions.
PSURs, PADERs, DSURs.
Promotional and medical review packages.
Registration maintenance & commitments.

Never-ending authoring and compliance workload.

Built to handle the hardest parts of Regulatory Authoring

Each feature is designed around real submission workflows, helping teams draft, review, and maintain dossiers with speed, accuracy, and confidence.

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Built to handle the hardest parts of Regulatory Authoring

Each feature is designed around real submission workflows, helping teams draft, review, and maintain dossiers with speed, accuracy, and confidence.

Proven impact for regulatory teams.

From faster ANDA dossier authoring to fewer cross-document errors and quicker label update cycles, SyncIQ delivers real, auditable gains across the entire regulatory content lifecycle.

80%

Reduced time to first draft

60%

Fewer inconsistencies

40%

Faster time to assess

1000+

Human hours saved

Designed to meet the standards of high-stakes regulatory authoring.

Every word accounted for.

Fully traceable

All generated content maintains clear links to its original sources, enabling fast review, validation, and inspection-ready traceability.

Region-ready by design.

Region-specific templates

Author content using predefined, region-aligned regulatory templates that guide structure, requirements, and formatting from the start.

Human oversight. Always.

Human in the loop

SyncIQ supports expert-led workflows where humans review, edit, and approve all content before updates.

Trusted by Regulatory, Clinical, and CMC teams worldwide

"We used SyncIQ's Regulatory CoPilot primarily for regulatory authoring, and it genuinely changed how our team works. First drafts come together quickly, and our writers spend time refining substance instead of assembling content from scratch."

Senior Director.

CMC & Regulatory Strategy, Global Pharma

"Compliance used to be the most stressful part of our process. With SyncIQ, we can now identify gaps and inconsistencies early, which gives us confidence that what we submit is complete, aligned, and defensible before it ever reaches regulators."

Chief Regulatory Officer.

Biotech Manufacturing

"Refining content became much easier with SyncIQ. Having a Guidelines Agent on standby is incredibly useful. We can ask FDA-related questions in plain language and get clear, contextual answers without digging through our documents."

Head of Regulatory Affairs.

Leading pharmaceutical manufacturing Company, India

Set the pace for innovation in life sciences with SyncIQ

Learn how SyncIQ can help your organization file faster, scale smarter, and bring medical breakthroughs to patients months ahead of schedule.

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Build Regulatory Content with Confidence

Trusted by

Your Second Brain

for Regulatory Compliance

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Across the drug lifecycle, regulatory teams manage expanding volumes of interdependent documents, where small inconsistencies introduce risk and cause significant downstream delays.

High-volume documentation to move from discovery to registration.

Complex submissions required to secure market authorization.

Ongoing documentation to maintain global market access.

Built to handle the hardest parts of Regulatory Authoring

Built to handle the hardest parts of Regulatory Authoring

Proven impact for regulatory teams.

Designed to meet the standards of high-stakes regulatory authoring.

Fully traceable

Region-specific templates

Human in the loop

Trusted by Regulatory, Clinical, and CMC teams worldwide

Trusted by Regulatory, Clinical, and CMC teams worldwide

"With SyncIQ’s AI agents, our formulary verification process is not only faster but far more reliable. What used to take weeks across payers now happens in days, giving us a real edge in market access."

"SyncIQ’s AI-driven CAPA and SOP management brought instant visibility to our quality processes. We’re catching issues earlier, and audits are smoother than ever."

"SyncIQ’s AI agents have revolutionized our health claims process. What once took days of manual effort is now completed with speed, accuracy, and complete traceability. Our teams can finally focus on delivering better service to policyholders."

Set the pace for innovation in life sciences with SyncIQ